November 21, 2009
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Tussionex

(phenyltoloxamine - hydrocodone)

DIN (Drug Identification Number)

01916971 TUSSIONEX SUSPENSION
01916963 TUSSIONEX TABLET SA

What side effects are possible with Tussionex?

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor. Your health professional may be able to help you deal with some of the effects.

The following side effects may go away as your body becomes used to the medicine; check with your doctor if they continue or become bothersome.

Less common or rare:

  • constipation (mild)
  • drowsiness
  • dryness of mouth

Check with your doctor as soon as possible if any of the following side effects occur:

Less common or rare:

  • clumsiness or unsteadiness
  • convulsions (seizures)
  • drowsiness (severe)
  • dryness of mouth, nose, or throat (severe)
  • flushing or redness of face
  • hallucinations
  • restlessness (severe)
  • shortness of breath or troubled breathing
  • slow or fast heartbeat

Get emergency help immediately if any of the following signs of overdose occur:

  • cold, clammy skin
  • confusion (severe)
  • convulsions (seizures)
  • drowsiness or dizziness (severe)
  • nervousness or restlessness (severe)
  • pinpoint-sized pupils of eyes
  • slow heartbeat
  • slow or troubled breathing
  • weakness (severe)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for Tussionex?

Addiction potential: This medication contains hydrocodone and therefore may be habit-forming.

Constipation: This medication may cause constipation or worsen existing constipation. People with chronic constipation should talk to their doctor about the risks and benefits of this medication.

Medical conditions: People with high blood pressure, diabetes, overactive thyroid, glaucoma, heart disease, and blood vessel disease should be closely monitored by their doctor while taking phenyltoloxamine - hydrocodone.

Occupational hazards: People who take phenyltoloxamine - hydrocodone are cautioned not to operate vehicles or hazardous machinery until they determine their response to the medication.

Sedation: The sedating effects of phenyltoloxamine - hydrocodone are additive to those of other sedating medications. Avoid drinking alcohol or taking hypnotics/sedatives, tricyclic antidepressants, benzodiazepines, or other narcotic medications during treatment with this medication.

Pregnancy and breast-feeding: The use of this medication during pregnancy is not recommended. Babies of nursing mothers using narcotics such as hydrocodone may become physically dependent on the medication. For this reason, phenyltoloxamine - hydrocodone should not be used by breast-feeding mothers.

What other drugs could interact with Tussionex?


The following medications may affect how this medication works or increase the risk of side effects:
  • alcohol
  • antihistamines that cause drowsiness (e.g., chlorpheniramine)
  • barbiturates (e.g., phenobarbital, secobarbital)
  • benzodiazepines (e.g., diazepam, lorazepam)
  • beta-blockers (e.g., metoprolol, atenolol)
  • MAO inhibitors (e.g., phenelzine, tranylcypromine)
  • methyldopa
  • other narcotic medications (e.g., codeine, morphine)
  • phenothiazines (e.g., chlorpromazine)
  • tricyclic antidepressants (e.g., amitriptyline, desipramine)

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. In many cases, interactions are intended or are managed by close monitoring. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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